Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0008-2014 — Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.

U.S. FDA — Device Enforcement · United States · 2013-08-14 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0008-2014
Date of alert: 2013-08-14
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Draeger Medical, Inc.
Product category: device
Product type: Devices

Reported risk: During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0008-2014 — Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.

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